tx-May292026-24: 25 TAC §229.420 (Amendment) — Food and Drug
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The executive commissioner of the Texas Health and Human Services Commission (HHSC), on behalf of the Texas Department of State Health Services (DSHS), proposes an amendment to §229.420, concerning Medical Gases. BACKGROUND AND PURPOSE The proposed amendment to Title 25 of the Texas Administrative Code (TAC) Chapter 229, Subchapter W, relating to Licensing of Wholesale Distributors of Prescription Drugs--Including Good Manufacturing Practices (GMP) is required to continue adherence with applicable federal laws pertaining to medical gases. Specifically, the proposed amendment aligns the minimum standards in the current rule with new Medical Gases GMP requirements under 21 Code of Federal Regulations (CFR) Part 213 and 21 CFR Part 230, which are already in effect. The proposed amendment will adopt the new 21 CFR Part 213 and 21 CFR Part 230 in 25 TAC §229.420(a). SECTION-BY-SECTION SUMMARY The proposed amendment to §229.420 updates federal reference citations and updates numbering for consistency throughout this section. FISCAL NOTE Christy Havel Burton, Chief Financial Officer, has determined that for each year of the first five years that the rule will be in effect, enforcing or...
The agency’s own summary, as published.
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